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Friendship Based HIV/STI (Sexually Transmitted Infections) Intervention for African American Females

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ClinicalTrials.gov Identifier: NCT00109421
Recruitment Status : Completed
First Posted : April 28, 2005
Last Update Posted : February 28, 2017
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Description
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Brief Summary:
The Project ÒRÉ intervention is a half-day community-based HIV/STI intervention program for friendship groups of adolescents that is tailored to African American culture. The four participating community sites will be assigned to either the Project ÒRÉ intervention or a standard health promotion program. Sexually experienced African American adolescent females will recruit members of their friendship group for the five-hour program. All participants will complete questionnaires before and immediately following the programs and another one 3 months later. Immediately following the program some of the Project ÒRÉ groups will also participate in a focus group to provide feedback about the program.

Condition or disease Intervention/treatment Phase
Sexual Behavior Sexually Transmitted Diseases HIV Infections Behavioral: Project ÒRÉ Not Applicable

Detailed Description:
A group-randomized controlled design to test the efficacy of the Project ÒRÉ intervention, a community-based adolescent social network HIV/STI intervention tailored to African American culture. Four community based organization sites (CBOs) will be randomly assigned to an experimental or attention control condition. In both conditions, sexually experienced African American adolescent females will recruit members of their friendship group for the five-hour program. In the experimental condition, the intervention group will receive the half-day Project ÒRÉ intervention. The attention control group will receive a standard health promotion control program which has been used previously with similar populations. All participants will complete pre-, post- and 3-month follow-up self-administered questionnaires. In the experimental condition, a subset of groups will participate in a process evaluation focus group immediately following the program.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: PROJECT ÒRÉ: An Innovative Friendship Based HIV/STI Intervention for High Risk African American Females
Study Start Date : November 2004
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental arm
In the experimental condition, the intervention group will receive the half-day Project ÒRÉ intervention. All participants will complete pre-, post- and 3-month follow-up self-administered questionnaires. A subset of groups will participate in a process evaluation focus group immediately following the program.
 Behavioral: Project ÒRÉ
Community-based adolescent social network HIV/STI intervention tailored to African American culture
Other Name: ÒRÉ
No Intervention: Attention control group
The attention control group will receive a standard health promotion control program which has been used previously with similar populations. All participants will complete pre-, post- and 3-month follow-up self-administered questionnaires.


Outcome Measures
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Primary Outcome Measures :
  1. Conduct elicitation research in the study community [ Time Frame: 18 Months ]
    To conduct elicitation research in the study community to: assess the applicability of the existing Project ÒRÉ intervention modules, modify the intervention for the specific populations that are targeted in the current study, and incorporate local data in the production of three brief videos involving youth in the study community


Secondary Outcome Measures :
  1. Test the efficacy of the intervention [ Time Frame: 18 Months ]
    To use a group-randomized controlled design to conduct a test of the efficacy of the Project ÒRÉ intervention.

  2. Conduct a qualitative process evaluation [ Time Frame: 18 Months ]
    To conduct a qualitative process evaluation to assess the acceptability of the experimental intervention in a new community using a subset of the participants in the experimental condition.


Eligibility Criteria
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Ages Eligible for Study:   14 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female
  • Between the ages of 14-18
  • Self-identifies as African American
  • Sexually experienced
  • Willing to participate in a single five-hour workshop and a one-hour follow-up session
  • Willing to nominate 2-5 close female friends ages 14-21 to participate in the study with her
  • Lives in the experimental intervention community
  • Ability to obtain permission from parent or legal guardian and assent from minors or consent from those above age of majority

Exclusion Criteria:

  • Individual reports predominantly same gender sexual behavior
  • Recent homelessness
  • Visibly distraught or unstable (i.e. suicidal, manic, exhibiting violent behavior, etc.)
  • Intoxicated or under the influence of psychoactive agents
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00109421


Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
Principal Investigator: M. Margaret Dolcini, Ph.D. University of California, San Francisco
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00109421     History of Changes
Other Study ID Numbers: ATN 034
First Posted: April 28, 2005    Key Record Dates
Last Update Posted: February 28, 2017
Last Verified: February 2016

Keywords provided by University of North Carolina, Chapel Hill:
adolescent
female
community-based
 social network
HIV/STI intervention
High HIV-risk African American adolescent females

Additional relevant MeSH terms:
Infection
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
 Virus Diseases
Sexually Transmitted Diseases, Viral
Immunologic Deficiency Syndromes
Immune System Diseases
Genital Diseases, Male
Genital Diseases, Female